Device recall
Z-3019-2017: VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105…
FDA device recall · Class II · Cyberonics, Inc
Key facts
| Recall number (Z-number) | Z-3019-2017 |
|---|---|
| Recall event | 77698 |
| Product | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years… |
| Product code | LYJ |
| Recalling firm | Cyberonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2023 |
| PMA numbers | P970003, P970003S117 |
| FEI number | 1000117004 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database